Maridebart cafraglutide official-source update · version 1
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Official-source update
Reviewed 2026-09-19 · Preserved version 1
The first study included an open-label part
Although NCT04478708 has an overall masked-trial designation, its participant-flow description says parts A and B were randomized and blinded while part C was open-label. Treating every participant as part of the same blinded comparison would misdescribe the evidence. NCT04478708 ↗
More findings and the sources behind them
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
Posted phase 1 results emphasize exposure and safety
The completed 110-participant phase 1 record posts pharmacokinetic, adverse-event and antibody outcomes. Its results table does not contain a body-weight outcome, so a published weight estimate requires its separate source and analysis context. NCT04478708 ↗
The phase 2 study asks a longer-term weight question
NCT05669599 records 592 participants across cohorts with and without type 2 diabetes. The registered primary endpoint is percentage body-weight change at week 52; the total enrollment is not a single outcome-analysis denominator. NCT05669599 ↗
The larger trial lacks posted registry results in this snapshot
The phase 2 record is marked completed, with a January 20, 2026 last-posted update, but no summary-results section in the retrieved payload. That does not invalidate or replace separately published clinical reports. NCT05669599 ↗
What remains to be checked
- Appraise the phase 1 and phase 2 publications, including weight outcomes absent from these registry results.
- Reconcile longer follow-up and adverse-event reporting across blinded and open-label parts.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity ↗
Source dated 2025-12-10; retrieved 2026-09-19.
- protocolSection.identificationModule, designModule and armsInterventionsModule
- resultsSection.participantFlowModule
- resultsSection.outcomeMeasuresModule
SHA-256:
70f00f3032e9c27fe1160ddda7e00030ce4b6d55ad7ff7e8032fc8a04a92e8efDose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus ↗
Source dated 2026-01-20; retrieved 2026-09-19.
- protocolSection.identificationModule, designModule and armsInterventionsModule
- protocolSection.eligibilityModule and armsInterventionsModule
- protocolSection.outcomesModule
- protocolSection.statusModule; presence or absence of resultsSection in retrieved record
SHA-256:
9e9f041791a3a6a56e9849cd26473df206cb7e8a414648d702bbdd97761f2bea